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NCT03580759 · ClinicalTrials.gov registry record · NA
Exergaming in Advanced HF With Multiple Chronic Conditions Prior to LVAD Implantation or Heart Transplant
A NA study, sponsored by University of Nebraska.
- Completed
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT03580759 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 2 participants.
The verdict
NCT03580759, a NA study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to test a home-based exergaming intervention designed to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced heart failure (HF) and multiple chronic conditions (MCC) prior to receiving either a left ventricular assist device (LVAD) or orthotopic heart transplantation (OHT). Prior to surgery, individuals with advanced HF/MCC experience a high symptom burden that often precludes them from participating in meaningful physical activity. Pre-surgical fitness programs have been used in other critically ill populations to improve function prior to surgery. Interactive gaming systems have been successfully used to engage other seriously ill adults in low-intensity physical activity. However, exergaming interventions have not yet been applied in individuals with advanced HF/MCC as prehabilitation prior to LVAD implantation or OHT. The investigators propose that a prehabilitation exergaming intervention will not only enhance pre-surgical outcomes but will also augment postoperative outcomes. This study is designed in two-phases. Phase 1 examines intervention feasibility and phase 2 is a pilot study with a two-group design. In phase 2, participants will be randomized to a usual care group or the exergaming intervention group. The exergaming group will participate in a low-intensity exergaming intervention and additional investigator-developed educational modules that will be delivered via the Nintendo Wii U exergaming system. The investigators will evaluate pre- and post-surgical frailty, fatigue, affective well-being, and immune function as primary outcomes. The investigators expect that participation in low intensity exergaming will improve these primary outcomes pre- and post-surgically, and decrease post-surgical complications and health care utilization. Investigator-developed modules will promote self-efficacy, self-regulation, and activation. This is the first s
Interventions
- BEHAVIORAL PREHAB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2021-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03580759
The ClinicalTrials.gov registry entry for NCT03580759 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PREHAB is the first listed.
NCT03580759 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03580759 about?
NCT03580759 is a clinical study titled "Exergaming in Advanced HF With Multiple Chronic Conditions Prior to LVAD Implantation or Heart Transplant". The purpose of this study is to test a home-based exergaming intervention designed to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced heart failure (HF) and multiple chronic conditions (MCC) prior to receiving eithe...
What is the current status of trial NCT03580759?
This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2019-03-01. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT03580759?
The interventions under investigation include: PREHAB (BEHAVIORAL).
Who is sponsoring clinical trial NCT03580759?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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